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ONITT: Onivyde Combo for Solid Tumors/Ewing Sarcoma

About this study

Some children, teens, and young adults have solid tumors that come back (recurrent) or do not get better with standard treatments (refractory). When that happens, these cancers can be very hard to treat, and there are limited options when usual therapies stop working. New treatment ideas are needed to give these patients a better chance.

This study is testing 2 drug combinations for children and young adults with solid tumors, including Ewing sarcoma: onivyde with talazoparib or onivyde with temozolomide.

These medicines work by damaging the DNA inside cancer cells or by preventing the cells from repairing that damage. The goal is to see if these combinations of drugs can kill more cancer cells in a safe way.

The goal of the first part of the study, called Phase 1, was to find the right doses of these drug combinations that patients can safely take. This part is finished. The study found doses that are safe enough to use in more patients. 

Now, the study is opening new groups to test these doses in more patients. This part aims to find out how well each drug combination works at the safe doses found in Phase 1: 

  • One group will receive onivyde with talazoparib. 
  • The other group will receive onivyde with temozolomide. 

The new groups of patients are:

  • Phase 1 expansion cohort: These patients have recurrent or refractory solid tumors (not Ewing sarcoma). They will receive either onivyde plus talazoparib or onivyde plus temozolomide. The treatment is chosen by the treating physician.
  • Phase 2: These patients have Ewing sarcoma. They will be assigned at random to 1 of the 2 treatments. It is a lot like flipping a coin, except that it is done by computer. Neither the patient nor the doctor will choose the treatment given.

Researchers want to know if the treatments can shrink the cancer, slow it down, or improve survival. Results of this study may guide future treatment options for young people with difficult-to-treat solid tumors.

Eligibility overview

  • 1–30 years old
  • Recurrent or refractory solid tumors

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

A Randomized Phase 1/2 Study of Talazoparib or Temozolomide in Combination with Onivyde in Children with Recurrent Solid Malignancies and Ewing Sarcoma

Study goal:

To study 2 drug combinations (onivyde with talazoparib, and onivyde with temozolomide) for children, teens, and young adults with relapsed or refractory solid tumors, including Ewing sarcoma

Diagnosis:

Solid tumors, Ewing sarcoma

Age:

1–30 years

Clinical trial categories:

Childhood Cancer Solid Tumors Ewing Sarcoma

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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